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ISO 18362:2016
Manufacture of cell-based health care products — Control of microbial risks during processing
Automatically translated name:
Manufacture of cell-based health care products -- Control of microbial risks during processing
STANDARD published on 15.1.2016
The information about the standard:
Designation standards: ISO 18362:2016
Publication date standards: 15.1.2016
SKU: NS-625119
The number of pages: 32
Approximate weight : 96 g (0.21 lbs)
Country: International technical standard
Category: Technical standards ISO
The category - similar standards:
Annotation of standard text ISO 18362:2016 :
Description / Abstract: ISO 18362:2016 specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled sterile and to CBHPs not labelled sterile. ISO 18362:2016 is not applicable to: - procurement and transport of cell-based starting material used in processing of a CBHP, - cell banking, - control of genetic material, - control of non-microbial product contamination, - in vitro diagnostics (IVDs), or - natural medicines. EXAMPLE Vitamins and minerals, herbal remedies, homoeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics, other products such as amino acids and essential fatty acids. ISO 18362:2016 does not define biosafety containment requirements. ISO 18362:2016 does not replace national or regional regulations that apply to the manufacture and quality control of a CBHP.
These changes apply to this standard:
ISO 18362:2016/Amd1:2022
Change
Show all technical information.
Manufacture of cell-based health care products — Control of microbial risks during processing — Amendment 1
(Manufacture de produits de soins de santé fondés sur les cellules — Contrôle des risques microbiaux durant le processus — Amendement 1)
Change published on 21.6.2022
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